Prospectively randomized, double-blind, multicenter phase II trial comparing the efficacy of chemotherapy with gemcitabine plus cisplatin and sorafenib versus gemcitabine plus cisplatin and placebo in the treatment of advanced or metastatic urothelial carcinoma SUSE - AB 31/05
- Conditions
- bladder cancerC67Malignant neoplasm of bladder
- Registration Number
- DRKS00003397
- Lead Sponsor
- niversitätsklinikum Essen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 99
Condition ECOG(Eastern Cooperative Oncology Group) 0-1
- Life expectancy at least 12 weeks
- Women in conceptional age: negative pregnancy test and adequate contraception (oral contraceptive, spiral); at men adequate contraception of the man (condom use) to 3 months after discontinuation of therapy with sorafenib
- Histologically or cytologically proven urothelial carcinoma of the bladder or upper urinary tract
- Locally advanced or metastatic urothelial carcinoma of the bladder or upper urinary tract (T3b,T4/ N+/M+)
- At least one unidimensional measurable lesion on CT(Computed Tomography) or MRI(Magnetic resonance imaging) according to RECIST(Response Evaluation Criteria in Solid Tumors) criteria
- Adequate hematologic, renal, hepatic and coagulation-physiological functions
- Absence of the above inclusion criteria
- Dialysis after nephrectomy
- Patients with brain tumors and / or brain metastases
- Previous or existing serious cardiovascular (grade III - IV according to NYHA(New York Heart Association)) disease, active angina pectoris or ischemia, myocardial infarction within 6 months prior to enrollment, or patients with serious cardiac arrhythmias requiring antiarrhythmic therapy (beta blockers and digoxin are permitted)
- Patients with uncontrolled high blood pressure, systolic blood pressure> 150 mm Hg or diastolic pressure> 90 mmHg despite optimal medical treatment
- Patients with thrombotic or embolic events such as stroke or pulmonary embolism
- Patients with recently or known bleeding diathesis
- Known significant neurological or psychiatric diseases including dementia and epileptic seizures
- Serious inflammatory eye disease, hearing impairment
- Pulmonary (pO2(Blood oxygen) <60 mm Hg(Millimeters of mercury)), hematopoietic (eg(exempli gratia) severe bone marrow aplasia), hepatic or renal disease
- Patients with poorly controlled diabetes mellitus
- Serious bacterial or fungal infections(>Grade 2 NCI-CTC(National Cancer Institute-Common Terminology Criteria) Version 3)
- chronic hepatitis B or C, HIV(human immunodeficiency virus) infection
- Autoimmune disease
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival [ Time Frame: 5 years ]
- Secondary Outcome Measures
Name Time Method - Response rates, time of response [ Time Frame: 5 years ] <br>- Time to progression [ Time Frame: 5 years ] <br>- Overall survival [ Time Frame: 5 years ]<br>- Evaluation and comparison in both treatment arms [ Time Frame: 5 years ]<br>